Dentsply Sirona Palodent V3 Instrucciones De Uso página 2

Palodent® V3
Sectional Matrix System
DIRECTIONS FOR USE – ENGLISH
Caution: For dental use only. USA: Rx only.
1. PRODUCT DESCRIPTION
The Palodent V3 Sectional Matrix System employs a nickel-titanium retaining ring, interproximal wedge,
®
WedgeGuard and sectional matrices for placement of restorations in the posterior region. Sectional matrices
are suitable for use with all posterior restorative materials. Palodent
non-stick finish that minimizes the chance that bonding agent or composite sticks to the band, making matrix
removal easier. The retaining rings are available in narrow, for most premolar and small molars or universal,
for larger molars. Rings may be used either singly or in tandem, for simultaneous restoration of multiple
surfaces. The advantages of the sectional matrices and rings include natural contours for better control
of contact areas and embrasures, ease of placement, better visualization of the operative field, and more
comfort for the practitioner and patient. Eliminating the leverage of a conventional matrix retainer allows the
practitioner to use less tension, avoiding excessive compression of tooth and easier formation of anatomical
proximal contact areas. When placed prior to preparation, the innovative WedgeGuard combination wedge
and shield protects approximating surfaces from inadvertent damage during preparation. Using the pin
tweezers, the shield easily slides away, leaving the wedge securely in place.
1.1 Delivery forms
(Some delivery forms may not be available in all countries)
• Sectional matrices are available in regular polished stainless steel or color-coded, non-stick Palodent
EZ Coat in 5 sizes: 3.5mm, 4.5mm, 5.5mm, 6.5mm and 7.5mm. These matrices are suitable for use with all
posterior restorative materials.
• Retaining rings are available in narrow (dark blue) and universal (light blue) sizes suitable for use in the
posterior region either singly or
in tandem.
• Wedges and WedgeGuards are available in small (dark blue), medium (medium blue) and large (light blue)
sizes.
1.2 Composition
• Sectional Matrices and WedgeGuard shield: Polished stainless steel;
Palodent V3 EZ Coat matrices: Whitford 8820HR-coated polished stainless steel
®
• Retaining rings: Nickel-Titanium with Glass Fiber Reinforced Tines
• Wedge and WedgeGuard: Polyacetal Thermoplastic
• Placement forceps and pin tweezers: 420 Stainless steel
1.3 Indications
• The Palodent V3 System is indicated for Class II restorations to facilitate the contouring of a
®
direct placement
restorative materials.
• The Palodent V3 WedgeGuard is indicated for pre-operative placement to protect surfaces adjacent to
®
Class II, Class III, veneer and crown preparations.
1.4 Contraindications
None known.
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special safety notes in other chapters of these
directions for use.
Safety alert symbol
This is the safety alert symbol. It is used to alert you to potential personal injury hazards. Obey
all safety messages that follow this symbol to avoid possible injury.
CAUTION
2.1 Warnings
1. The Palodent V3 System consists of small, sharp parts. As with all intraoral instruments, care must be
®
exercised to ensure stable handling and placement. Placement of rubber dam or other suitable isolation is
advised prior to operative procedures. Wear suitable protective eyewear and gloves.
Aspiration: If aspiration of matrix, wedge, WedgeGuard, or retaining ring occurs seek immediate medical
attention.
Ingestion: If accidental swallowing occurs, encourage patient to seek medical assistance to locate
swallowed part. If nausea or illness develop, seek medical attention immediately.
Laceration: The Palodent V3 matrices and WedgeGuard shields are sharp, and may cut unprotected skin.
®
Handling matrices and WedgeGuard shields with gloved hands and/or pin tweezers or similar instrument
is recommended. In the event a clean matrix or WedgeGuard shield causes a skin laceration, employ usual
first aid measures. Discard and properly dispose matrix or
WedgeGuard shield.
2. Used matrices and accessories are contaminated. Follow proper exposure control plans. In the event of an
accidental exposure, follow recommended post-exposure procedures. Following use of the Palodent
System, proper handling and disposal techniques are required. Used matrices are contaminated and sharp.
When handling or disposing, use precautions as when handling or disposing other contaminated sharps.
3 . Care should be taken to have good control on any instrument to protect patients from injury.
4. When properly placed, retaining rings exert a clamping force for stabilization. Use of narrow rings on
large prepared molars, or use of any ring on teeth compromised by extensive preparation and/or with
unsupported tooth structure may lead to tooth crazing or fracture. For compromised teeth, consider
alternative matrix retainer.
2.2 Precautions
1. This product is intended to be used only as specifically outlined in the Directions For Use. Any use of
this product inconsistent with the Directions For Use is at the discretion and sole responsibility of the
practitioner.
2. Care must be taken when placing the retaining ring, due to the spring nature of the ring. Ensure ring
is fully seated in forceps before placement. Before withdrawing forceps, check that the ring is seated
securely apically (see Step-by-step Instructions). Tie dental floss to the Palodent
security.
3. Excessive pressure on matrix, wedge, WedgeGuard, or retaining ring in an apical direction may result in
injury to periodontal tissues.
4. Devices marked "single use" on the labeling are intended for single use only. Discard after use. Do not
reuse in other patients in order to prevent cross-contamination.
5. Do not use accessory tools other than those designed, supplied, and/or outlined for use with the Palodent
V3 System. Injury may result. (See Step-by-Step Instructions)
V3 EZ Coat matrices have a micro-thin,
®
V3
®
V3
®
V3 ring for added
®
®
2.3 Adverse reactions
1. Product misuse may cause failure resulting in respiratory, digestive, eye, skin, or mucosa injury. (See
Contraindications, Warnings
and Precautions)
2. Failure to properly employ accepted handling and disposal techniques may present biohazard. (See
Warnings and Precautions)
3. Use of narrow retaining rings on large teeth, or use of any retaining ring on weakened or unsupported
tooth structure may lead to tooth fracture (See Warnings)
2.4 Storage conditions
Store at temperatures between 10-24°C/50-75°F, away from moisture or excessive humidity. Keep out of
sunlight. Keep away from flame or source of ignition.
3. STEP-BY-STEP INSTRUCTIONS
1. Pre-operative Sterilization
Matrices, wedges and WedgeGuards are intended for single use. If desired, these components may be
steam autoclaved one time (134°C, 3 minutes minimum holding time) prior to clinical use. Retaining rings,
forceps and pin tweezers are not supplied sterile, and should be steam autoclaved prior to first and each
subsequent use (see Hygiene section).
2. Place rubber dam or other suitable isolation technique.
3. Pre-operative Placement (optional)
1. WedgeGuard placement
Prior to preparation, select the appropriate sized WedgeGuard, and place interproximally. Palodent
WedgeGuards contain a placement tab with hole, which is securely grasped by the pin tweezers. Do
not use excessive force.
OR
2. Ring Placement
To effectively use a contoured sectional matrix, there must be enough interproximal space to position
the matrix without force or distortion. The retaining ring, when placed prior to and left on during cavity
preparation, provides the necessary separation with no additional chair time. NOTE: Do not place
retaining ring pre-operatively if WedgeGuard is used. Follow these ring placement instructions after
preparation completion, shield removal and matrix placement, (step 7).
To place the ring, grasp it within at its widest diameter with the provided forceps, being sure the
ring rests within the channel on the forceps beaks. Spread the forceps to expand ring only enough
to clear tooth height of contour. Do not over-expand. Over-expansion may result in permanent ring
deformation. The locking slide on the forceps may be engaged to facilitate carrying and placement of
the ring.
Place the ring with one tine in each interproximal space from buccal to lingual adjacent to the surface
to be restored. The direction the ring points, mesial or distal, does not matter, though placing it so that
the ring points mesially is usually more easily achieved due to easier access.
With the tines properly positioned interproximally, release the locking slide, and slowly release the
forceps tension. When ring is securely seated, release the forceps completely and withdraw forceps.
Small parts under tension
• Be sure ring is securely seated in the forceps before introducing into the patient field.
CAUTION
• Be sure ring is securely seated apically before withdrawing forceps.
4. Cavity Preparation
Complete cavity preparation as usual. Once the preparation is complete, remove the ring or the metal
shield of the WedgeGuard (if applicable). Use the pin tweezers to grasp the hole on the WedgeGuard
shield, and slide shield laterally to remove. The wedge may remain in place if apical to the gingival
cavosurface margin. Properly dispose of the shield with contaminated sharps.
5. Matrix Selection
The 5.5mm Palodent V3 contoured sectional matrix is recommended for most applications. The 4.5mm
®
and 3.5mm are designed for use with adolescents and patients with poorly erupted posterior teeth.
They are also ideal for the direct-indirect technique. The 6.5mm matrix is designed for larger cavities
occlusogingivally. It augments a contoured matrix with a gingival apron and an adjustable continuation
of the contour at the marginal ridge. The 7.5mm matrix is useful for patients with periodontal issues that
require more coverage toward the gingival margin.
Technique Tip: Rings, Matrices, Wedges and WedgeGuards may be used with most popular matrix
systems, including other sectionals. The Rings, Wedges and WedgeGuards may be used with most
circumferential matrices. The benefits of the Ring, Wedge and WedgeGuard contours assist proper
proximal contour.
6. Application of Matrix and Wedge
1. Grasp the matrix with the pin tweezers using the hole located on the occlusal tab. If the ring was placed
properly before tooth preparation, then the matrix should slide easily into place adjacent to the space
to be restored from the occlusal approach. Ensure matrix is apical to preparation margin with no gap.
Technique Tip: If WedgeGuard wedge prevents matrix from fully seating gingivally, slide wedge out
slightly, place matrix, then reposition wedge.
2. Close the gingival margin by placing a contoured wedge or anatomic wooden wedge. Palodent
wedges contain a placement tab with hole, which is securely grasped by the pin tweezers. This assures
secure placement and minimizes the likelihood of dropping small accessories. Technique Tip: Palodent
V3 wedges' hollow design allows for easy placement of a second wedge from the opposing side (if
needed) without dislodging the first. Technique Tip: Alternatively, the fork design allows placement of
the Palodent V3 retaining ring first if desired. The wedge can then be easily placed through the fork
®
tine without dislodging the ring.
7. Replace the Palodent V3 retaining ring in the proximal plane, engaging the matrix and the wedge, thus
®
stabilizing it against tooth structure. The forks of the tines should be sitting over the wedge.
8. Lightly burnish the matrix against the adjacent tooth both buccally and lingually to further adapt it to
form proper contours. NOTE: Over burnishing may distort matrix and compromise contours. The pin
tweezer has a built-in ball burnisher for this purpose. The matrix placement tab may be bent over the
adjacent marginal ridge to facilitate restoration marginal ridge contour. Technique Tip: When restoring
an MOD preparation, two rings may be placed facing opposite directions, one mesially and one distally or
both pointing in the same direction, usually mesially, one over the other placing the mesial matrix and ring
first.
9. Placement of Restorative
Place restorative material and establish proximal contact as per usual technique. Light cure and/or allow
material to reach initial set. Gross contouring may be accomplished with matrix in place.
10. Matrix Removal
Remove ring(s) using forceps, remove wedge(s) and sectional matrices using pin tweezers. Finish
contouring and verify appropriate proximal contact. Technique Tip: It is advisable to "post-cure" light
cured restorative materials following matrix removal from all surfaces, including proximo-facial and lingual
line angles.
2
V3
®
V3
®
®